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Title 21 → Chapter I → Subchapter E → Part 516 → Subpart E → §516.2065

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Title 21: Food and Drugs
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Subpart E—Conditionally Approved New Animal Drugs For Minor Use and Minor Species

§516.2065 Rabacfosadine.

(a) Specifications. Each vial of powder contains 16.4 milligrams (mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 mg rabacfosadine.

(b) Sponsor. See No. 086072 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer rabacfosadine at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once every 3 weeks, for up to 5 doses.

(2) Indications for use. For the treatment of lymphoma in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

[82 FR 12169, Mar. 1, 2017]

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